ARTICLE | Regulation
Lynparza panel vote advances FDA’s precision oncology agenda
ODAC votes for a biomarker-restricted label for Lynparza in prostate cancer
April 29, 2023 12:36 AM UTC
It’s been 25 years since Herceptin became the first therapy approved for a biomarker-defined subpopulation in the U.S., and regulators are still addressing the same question of whether to restrict labels.
On Friday, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted in favor of a narrow label for Lynparza olaparib plus abiraterone as first-line therapy for metastatic castration-resistant prostate cancer (mCRPC) that would restrict the population to the about 10% of patients with BRCA mutations...
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